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New smart socket aims to get amputees moving again

NCT ID NCT05656924

Symptom relief Sponsor: Spaulding Rehabilitation Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new type of prosthetic socket and liner designed to better distribute pressure on the remaining limb. Combined with an exercise program, the goal is to help people who lost a leg due to diabetes walk more and improve their health. About 38 participants who already use a prosthesis will be followed to see if the new socket leads to more daily steps and better comfort.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
digital prosthetic interface technology (special socket and liner)
What this could lead to
If it works, this could lead to a better-fitting prosthetic that helps people with diabetes-related amputations walk more and improve their overall health.
What could go wrong
This is a small, early-phase trial with only 38 participants, so results may not apply to everyone. The new socket may not significantly improve comfort or activity levels.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 38 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2023

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Unilateral transtibial amputation within the past 6 years * Etiology secondary to complications of Diabetes Mellitus (DM) type II * Current use of a prosthesis, with at least 2 months prior use * K2 or K3 level (as determined using the Amputee Mobility Predictor assessment tool) * Own a smartphone Exclusion Criteria: * Amputation due to cancer or macrotrauma or acute hemorrhage * Bilateral amputation * Medically or surgically unstable contralateral lower extremity as determined by medical criteria (e.g., critical limb ischemia) * Severe residual limb pain that limits function preventing participation in an exercise-based program * Medical conditions that would interfere with subject's participation in regular sustained exercise * Anthropometric characteristics that are not compatible with the technology used to scan the residuum and manufacture the liner and socket (e.g., a residuum circumference greater than 32 inches would not be compatible with the device used to scan the residuum) * Current pregnancy

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Conditions

The condition(s) this trial relates to.

type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Amputation Diabetes type 2

Contacts and locations

Locations

  • Spaulding Rehabilitation Hospital Boston

    Boston, Massachusetts, 02129, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.